FDA Hearing: Implementing the Import Provisions of the Food Safety Modernization Act

The authors recently attended the first of several U.S. Food and Drug Administration (FDA) hearings focusing on implementing portions of the Food Safety Modernization Act (FSMA).  They composed this summary of the proceedings.

This first hearing, held March 29, 2011 in Washington, D.C., examined FDA's implementation of Title III of FSMA—the provisions relating to imported foods.  Around 250 participants, including many from industry, advocate organizations, foreign governments, and certification agencies, attended the day-long meeting.  FDA staff indicated this meeting was to be a prototype for future meetings on implementing various sections of FSMA.

FDA Opening Remarks

The meeting began with opening remarks from FDA staff, including Deputy Commissioner for Foods, Michael Taylor.  Mr. Taylor announced what he saw as the four deeply embedded principles of FSMA: (1) Prevention of food hazards is the fundamental goal; (2) the food industry, including domestic firms and importers, have primary responsibility for prevention; (3) FDA has a broad mandate to set the standards for prevention and assure compliance with those standards; and (4) Congress recognized it was creating a multifaceted system and therefore partnerships and collaborations with industry, third party agencies, and foreign governments are key. 

FDA Deputy Commissioner for International Programs, Murray Lumpkin, then discussed FDA's focus on implementing the imported foods provisions and the FDA's role abroad.  Dr. Lumpkin emphasized FDA is still fundamentally a domestic public health agency, but that it must take into account globalization.  The difficulty will be maintaining this focus on domestic public health while not appearing self-centered.  Under Section 308 of the act, FDA is directed to establish foreign offices.  According to Mr. Lumpkin, these foreign offices have three goals: (1) to gather better information; (2) to encourage better collaboration with government counterparts in foreign countries and with the export industry; and (3) to leverage their financial, technical and inspection resources.  Dr. Lumpkin emphasized the importance of measuring the agency's success with metrics.

In order to accomplish the tight implementation schedule for the imported foods provisions, FDA has established four work groups.  These four work groups are: (1) foreign supplier verification program and voluntary qualified importer program; (2) third party certifiers/auditors; (3) foreign capacity building; and (4) accreditation of laboratories.   

Accredited Third-Party Certification Panel

The day's first listening session focused on accredited third-party certification.  This session revealed a major tension between industry groups, which urged FDA to adopt or otherwise utilize existing private industry or international standards (such as CODEX, GFSI, or GlobalGAP) rather than reinvent the wheel, and consumer groups which urged FDA to create and enforce its own national standards.  FDA appeared concerned with three issues here.  First, how to assure auditors are competent.  The second issue of concern was how to deal with auditors' potential conflicts of interest, such that FDA can have a high level of confidence in the integrity of the auditors' results.  Finally, FDA was concerned with whether third parties would have the capacity to hire and train the necessary number of qualified auditors in a short period of time. 

FDA staff deflected suggestions that FDA should simply adopt existing international standards, including HACCP standards.  However, they did indicate a business that moved ahead with a program in compliance with those standards would have an "excellent chance" of complying with FDA's new hazard analysis regulations, whenever they are issued.

Voluntary Qualified Importer Program and Foreign Supplier Verification Programs

The second listening session involved the Voluntary Qualified Importer Program (VQIP) and the Foreign Supplier Verification Program (FSVP).  A representative from the Pew Charitable Trust urged FDA to use the Seafood HACCP regulations as a model for implementing VQIP and FSVP.  She further indicated Pew would continue to be very involved in the rulemaking process.  Industry representatives urged FDA to implement data management tools to effectively and efficiently use the information it would gather through VQIP and FSVP to make risk-based decisions.  They urged FDA to focus on benchmarking and metrics in the rulemaking process, as well as to assure it works with other agencies involved in the import process, especially the Department of Homeland Security (DHS).  Industry advocates also urged FDA to build on what already exists, to focus on public health outcomes (rather than prescribing particular means of compliance) and harmonizing any rules with international standards. 

In the afternoon, FDA held small listening sessions to discuss implementation of VQIP and FSVP.  With respect to FSVP, FDA identified four areas of discussion: (1) who must comply; (2) what mechanisms can be used for verification; (3) how to identify the "importer"; and (4) whether rules should differ based upon the types of importers or types of foods involved.  FDA representatives noted the differing definitions of "importer" in VQIP versus FSVP sections of the FSMA.  A key issue with implementing both the FSVP and VQIP will be determining who is the responsible the "importer" and/or "agent".  FDA did not indicate which definition it was leaning towards, and officials urged participants to submit comments to the docket on this matter. Industry representatives and importers urged flexibility in what mechanisms affected parties utilize to verify compliance. 

The listening session regarding VQIP focused on four questions posed by FDA: (1) who should be allowed to participate; (2) what benefits FDA should provide to participants; (3) how this program should be integrated with other federal agency programs; and (4) what the effect of non-compliance should be.  Again, a key issue was defining what "importer" meant.  The general consensus was that FDA should broadly interpret this clause to allow many different types of businesses to participate in this voluntary program.  Another important issue raised by industry representatives was that in order for the VQIP to be successful, FDA would need to work closely with other agencies (including DHS and its C-TPAT program).  They argued it makes little sense for a company to pay fees to participate in this program to expedite their goods if the good would subsequently be slowed down by DHS or another agency.  In addition, importers and industry representatives indicated FDA should assure its regulations are fully in compliance with World Trade Organization (WTO) and other international trading rules, to avoid any trade retaliation from foreign governments. 

Other Issues:

·         Commissioner Taylor indicated the January 4, 2012 statutory deadline for FSVP was "fanciful," clearly implying that rules could not be issued by the deadline, because the issues were "too important" and "must be done carefully." 

·         FDA intends to work with industry every step of the way and indicated this hearing was "just the start of a dialogue."

·         Other FDA staff commented that they were looking to industry cooperation and collaboration to move the implementation process as quickly as they could.  

·         FDA indicated it was very sensitive to the costs imposed by the new regulations, especially costs on small businesses.

·         FDA will post an organizational chart of its FSMA implementation team to its website in the very near future. 

Key Take-Aways:

·         FSMA remains just a skeletal framework until regulations and guidance documents are created.

·         There is a real tension between consumer groups' desire to have FDA do all the work themselves and not rely on private actors for verification, and the reality that FDA will have to push some of its work to others given its lack of resources and budget concerns.

·         Industry is concerned FDA will try to reinvent the wheel with respect to food safety standards for imported foods rather than relying upon existing international systems and standards. 

·         FDA is still very much in listening mode and many basic questions regarding implementation of each of these provisions are still unanswered.

·         Consumer groups intend to be very active in the rulemaking process.  Industry groups should assure their viewpoints are heard. 

·         Comments can be submitted until April 29, 2011 at http://www.regulations.gov for the following programs:

o   Foreign Supplier Verification Program Docket: FDA-2011-N-0143

o   Voluntary Qualified Importer Program Docket: FDA-2011-N-0144

o   Authority to Require Import Certifications for Food Docket: FDA-2011-N-0145

o   Accreditation of Third-Party Auditors Docket: FDA-2011-N-0146

Faegre & Benson will continue to monitor and report back on future hearings and meetings as FDA moves forward with implementing various sections of the Food Safety Modernization Act.